BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1409256 · Received June 30, 2009

    Report

    Report Number
    2024168-2009-01161
    Event Type
    Injury
    Date Received
    June 30, 2009
    Date of Event
    February 1, 2009
    Report Date
    June 5, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL XIENCE V 3.0 X 18 MM 9LOT # 8071661); XIENCE V 3.0 X 08 MM (LOT # 8040961) MENTIONED ARE BEING FILED UNDER THE SAME MANUFACTURER NUMBER. ANGINA AND RESTENOSIS, AS LISTED IN THE IFU, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. ALSO, ANGINA, STENOSIS AND HOSPITALIZATION ARE LISTED IN THE RISK ASSESSMENT. THERE WAS NO REPORT OF ANY PRODUCT MALFUNCTION AT THE TIME OF THE STENT IMPLANTS. IT IS POSSIBLE THAT THE ANGINA IS A SECONDARY EFFECT OF THE RESTENOSIS WHICH WAS TREATED WITH PCI AND REQUIRED HOSPITALIZATION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT THE PT HAD A 3.5 X 12 MM, 3.0 X 18 MM AND A 3.0 X 8 MM XIENCE V STENT IMPLANTED. IN 2009, THE PT EXPERIENCED CHEST PAIN (ANGINA). THE PT WAS HOSPITALIZED. DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED IN-STENT RESTENOSIS AND PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED AS TREATMENT. NO ADDITIONAL EVENT OR PT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8051262

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R (LOT # 8071661)| (LOT # 8040961)| XIENCE V 3.0 X 08 MM| XIENCE V 3.0 X 18 MM